Policies and Procedures

POLICIES AND PROCEDURES

100. IRB Statement of Compliance *NEW 08/2020*

101. About the IRB *NEW 08/2020*

102. IRB Member Confidentiality

103. Federalwide Assurance/IRB Registration

104. IRB Review Process *NEW 08/2020*

105. Duties of IRB Members

106. InfoEd 21 CFR Part 11 Statement

107. Scientific Methodological Review

108. Expedited Categories

109. Medical Devices *NEW 11/2019*

110. Sponsor - Investigator Research Requirements (When a CU investigator holds the IND) *NEW 11/2019*

111. Guidelines for Genetic Research

112. Recruiting Research Participants

113. Exempt Research

114. External Studies

115. Vulnerable Research Populations

116. Prisoners in Research

117. Informed Consent, Permission, Assent

118. HIPAA for Researchers

119. Unanticipated Problems involving risks to participants or others

120. Continuing Review/ Project Termination

121. Modifications of Approved Research

122. Human Subject Research Education Program

123. Review of Human Subject Research Activities by other Creighton University Committees

124. Additional Department of Defense Requirements

125. Registering with Clinical Trials

126. Engaged in Research

127. Emergency Use of Unapproved Drugs/Devices/Biologics

128. Expanded Access to Investigational New Drugs

129. International Research

130. Non-compliant Conduct

131. Data and Safety Monitoring Plans

132. Community-Based Research

133. Reportable New Information

134. Suspensions and Terminations

135. Multi-Site

136. Certificate of Confidentiality

Policies have been revised to reflect the Revised Common Rule. The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017 and effective July 19, 2018. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.